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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01060475 |
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Date of registration:
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29/01/2010 |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of LIM-0705 in Healthy Male Subjects
LIM |
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 Given With or Without Tacrolimus in Healthy Male Subjects |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01060475 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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Albert Frauman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nucleus Network |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male age 18-50
- Patient in good health as deemed by pre-study exam and history
- BMI 20-30 kg/sq. meter
- Absence of tremors
- Must be willing to remain in confinement for 17 days/16 nights
- Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm
- Subject must be non-smoker or willing to abstain from smoking day -4 through day 30.
- Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages
starting Day -2 through Day 30.
- Subjects must use double-barrier contraception through course of study + 90 days
following study
Exclusion Criteria:
- Allergy to red wine or onions
- Strict vegetarians
- Use of any non-study medication
- Use of chemotherapy within 5 years prior to Screening visit
- Use of any dietary aids
- Difficultly swallowing oral medications
- cognitive or psychiatric disorders
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Drug LIM-0705 and placebo tacrolimus
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Drug: LIM-0705 and tacrolimus
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Drug: Placebo LIM-0705 and tacrolimus
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Primary Outcome(s)
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Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
[Time Frame: 14 days]
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Secondary Outcome(s)
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Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
[Time Frame: 14 days]
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Secondary ID(s)
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LIM-0705-CL-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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